Condition or disease | Intervention/treatment | Phase |
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Chronic Kidney Disease Stage 3 Anemia Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 5 | Drug: Desidustat Oral Tablet Drug: Darbepoetin Alfa | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 588 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Multicenter, Multi-country, Open-label, Randomized, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Desidustat Versus Darbepoetin for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Who Are Not on Dialysis |
Actual Study Start Date : | July 20, 2019 |
Estimated Primary Completion Date : | September 30, 2021 |
Estimated Study Completion Date : | December 30, 2021 |
Arm | Intervention/treatment |
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Experimental: Darbepoetin Alfa Injection
Randomly assigned to receive Darbepoetin in a 1:1 ratio for 24 weeks.
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Drug: Darbepoetin Alfa
Darbepoetin injection
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Active Comparator: Desidustat oral tablet
Randomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks.
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Drug: Desidustat Oral Tablet
Desidustat tablet
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: DrDeven Parmar, MD | +912717665555 ext 451 | deven.parmar@zydusdiscovery.ae | |
Contact: Dr Kevin Kansagra, MD | +912717665555 ext 279 | Kekevinkumarkansagra@zyduscadila.com |
Study Director: | DrDeven Parmar, MD | Cadila Healthcare Limited |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 7, 2019 | ||||||||
First Posted Date ICMJE | July 9, 2019 | ||||||||
Last Update Posted Date | November 10, 2020 | ||||||||
Actual Study Start Date ICMJE | July 20, 2019 | ||||||||
Estimated Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Hemoglobin level [ Time Frame: 24 weeks ] Change in Hb levels from baseline
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Desidustat in the Treatment of Anemia in CKD | ||||||||
Official Title ICMJE | A Phase 3, Multicenter, Multi-country, Open-label, Randomized, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Desidustat Versus Darbepoetin for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Who Are Not on Dialysis | ||||||||
Brief Summary | This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anemia in patients with CKD who are not on dialysis. The study will be conducted over a period of up to 30 weeks. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
588 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 30, 2021 | ||||||||
Estimated Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | India | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04012957 | ||||||||
Other Study ID Numbers ICMJE | DESI.18.001 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Cadila Healthcare Limited | ||||||||
Study Sponsor ICMJE | Cadila Healthcare Limited | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Cadila Healthcare Limited | ||||||||
Verification Date | July 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |